frequently asked questions for

FREQUENTLY ASKED QUESTIONS FOR ELECTRONIC PRESCRIBING

Revised: November 2016

NEW YORK STATE DEPARTMENT OF HEALTH Bureau of Narcotic Enforcement

1-866-811-7957

www.health.ny.gov/professionals/narcotic

Electronic Prescribing Frequently Asked Questions

New York State Department of Health Page 1 Bureau of Narcotic Enforcement

Contents Laws and Regulations for Electronic Prescribing of Controlled Substances (EPCS)…..…………………Page 1

Physician Assistant and Pharmacy EPCS Registration Form……..…………………………..……………………Page 11

Registration for Official Prescriptions and E-prescribing Systems (ROPES)…………………………………Page 15

Software and Data Requirements……………………………………………………………………………………………..1

Waivers and Exceptions…………………………………………………………………………………………………………….Page 22

Online Electronic Prescribing Waiver Requests (EPW)……………………………………………………………….Page 24

Practitioner Reporting Requirement…………………………………………………………………………………………Page 59

Certifications…………………………………………………………………………………………………………………………….Page 60

Resource Information and Contacts………………………………………………………………………………………….Page 62

Laws and Regulations for Electronic Prescribing of Controlled Substances (EPCS)

Q1: What is Electronic Prescribing of Controlled Substances or EPCS?

A1: Amendments to Title 10 NYCRR Part 80 Rules and Regulations on Controlled Substances have been adopted and became effective as final regulations on March 27, 2013. The amendments authorize a practitioner to issue an electronic prescription for controlled substances in Schedules II through V and allow a pharmacist to accept, annotate, dispense and electronically archive such prescriptions. A definition of an electronic prescription can be found in Section 3302 Article 33 Public Health Law. Click

on the following link for Section 3302; Section 3302 Article 33 Public Health Law.

Q2: Is Electronic Prescribing mandatory for New York State practitioners? A2: As of March 27, 2016 it will be mandatory for practitioners, excluding veterinarians, to issue electronic prescriptions for controlled and non-controlled substances. Electronic prescribing of controlled substances will require additional security features and registration of the certified software application with the Bureau of Narcotic Enforcement. Q3: Why will electronic prescribing of controlled and non-controlled substances be mandatory effective March 27, 2016? A3: New York Education Law Article 137 §6810 requires that all prescriptions be transmitted electronically three years from the Department of Health’s promulgating regulations allowing for the electronic prescribing of controlled substances. These regulations became effective on March 27, 2013. Utilizing modern prescription technology has the potential to minimize medication errors for patients in New York State. Electronic prescribing also allows for the integration of prescription records directly into the patient’s electronic medical record. Electronic prescribing has the potential to reduce prescription theft and forgery.

http://www.health.ny.gov/professionals/narcotic/laws_and_regulations/



Q4: Will the use of Official New York State Prescription forms be prohibited as of March 27, 2016?

A4: Official New York State Prescription forms may be used in the event of a power outage or technical failure, or by practitioners who meet one of the exceptions listed in Article 2A - Section 281 or Title 10 Part 80 Section 80.64. Please review this section of the law and regulations, which may be accessed from the following links: Article 2A - Section 281 and Title 10 Part 80 Section 80.64 Q5: Should I return all of my unused Official New York State Prescription forms to BNE? A5: Not necessarily. Under limited circumstances, the use of an Official NYS Prescription form will still be allowed, including events of a power outage or technological failure. However, it is unlikely that practitioners and institutions will need to continue to keep a similar inventory as in the past. Please consider the amount of prescription paper you will need to keep on hand, safeguard any stored Official New York State Prescription forms and return unneeded or unwanted forms to the Bureau of Narcotic Enforcement at 150 Broadway, Albany, NY 12204. The Bureau of Narcotic Enforcement will continue to supply Official New York State Prescription forms to practitioners and institutions. Q6: I currently electronically prescribe non-controlled substances. Are there any additional steps I need to complete in order to electronically prescribe controlled substances?

A6: Yes.

• First, the software you currently use must meet all the federal security requirements for EPCS, which can be found on the Drug Enforcement Agency’s (DEA) web page. http://www.deadiversion.usdoj.gov/ecomm/e_rx/ Note that federal security requirements include a third party audit or DEA certification of the software.

• Second, you must complete the identity proofing process as defined in the federal requirements.

• Third, you must obtain a two-factor authentication as defined in the federal requirements. • Fourth, you must register your DEA certified EPCS software with the Bureau of Narcotic

Enforcement (BNE). Registration instructions are included in the FAQs.

Q7: Can I electronically prescribe controlled substances before it becomes mandated on March 27, 2016?

A7: EPCS became permissible in NYS on March 27, 2013. Practitioners can electronically prescribe controlled substances if:

• The EPCS software application meets all of the federal security requirements for EPCS, which can be found on the DEA’s web page. http://www.deadiversion.usdoj.gov/ecomm/e_rx/ Note that federal security requirements include a third party audit or DEA certification of the software.

• The practitioner has completed identity proofing as defined in the federal requirements and • The practitioner has obtained a two-factor authentication as defined in the federal

requirements and • The practitioner has registered their DEA certified EPCS software application with the Bureau

of Narcotic Enforcement (BNE). Please refer to the Registration instructions included below in the section titled “Registration for Official Prescriptions and E-prescribing Systems” or “Physician Assistant and Pharmacy EPCS Registration Form”, whichever is applicable.

http://public.leginfo.state.ny.us/LAWSSEAF.cgi?QUERYTYPE=LAWS+&QUERYDATA=$$PBH281$$@TXPBH0281+&LIST=LAW+&BROWSER=EXPLORER+&TOKEN=37797600+&TARGET=VIEW

http://w3.health.state.ny.us/dbspace/NYCRR10.nsf/56cf2e25d626f9f785256538006c3ed7/8525652c00680c3e8525652c006f1632?OpenDocument&Highlight=0,80.64

http://www.deadiversion.usdoj.gov/ecomm/e_rx/




Q8: If only 5 days or less of a controlled substance is prescribed, does the prescription need to be transmitted electronically? A8: Yes. Any amount of controlled substances being prescribed requires the prescription to be transmitted electronically. An exception to this is that a paper or oral prescription may be issued for a controlled substance, that does not exceed a 5 day supply, ONLY if the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, AND such delay would adversely impact the patient’s medical condition. Q9: Can a prescriber fax a prescription to a pharmacy after March 27, 2016? A9 Yes, under very limited circumstances defined in Public Health Law (PHL) Section 281(3) and The Commisioner of Health's Letter, provided that the following criteria are met: a. Must be a fax of an original hard copy prescription; b. Must be manually signed by the prescriber; and c. If issued in NY, must be on an Official New York State Prescription form. In most instances, faxed prescriptions for controlled substances must comply with requirements for oral prescriptions for controlled substances, including issuance of the follow-up prescription. A facsimile is not an electronic prescription and must bear a manual signature. Q10: Will it be permissible for a NY practitioner to fax a prescription for a 30 day supply of a controlled substance for a patient in a Hospice Program or a RHCF to a NY pharmacy once e-prescribing becomes mandatory? A10: No, unless the prescription is issued pursuant to one of the exceptions in the regulation, 10NYCRR Sec. 80.64. Faxed prescriptions are not considered electronic prescriptions. Q11: Is an electronic facsimile of a prescription considered an electronic prescription?

A11: No. A definition of an electronic prescription can be found in Section 3302 Article 33 Public Health

Law and specifically states that a prescription generated on an electronic system that is printed out or transmitted via facsimile is not considered an electronic prescription. Click on the following link for Section 3302: Section 3302 Article 33 Public Health Law.

Q12: Is it permissible for an intermediary to convert an electronic prescription for a controlled substance to an electronic fax in the event of a transmission failure?

A12: At no time may an intermediary convert an electronic prescription for a controlled substance to facsimile for transmission to the pharmacy if the electronic transmission fails. Q13: Is it permissible for an intermediary to convert a non-controlled substance electronic Prescription to an electronic fax in the event of a transmission failure of the electronic prescription?

A13: At no time may an intermediary convert an electronic prescription to a facsimile prescription for transmission to the pharmacy if the electronic transmission fails. Education Law, Section 6802 specifically

https://www.health.ny.gov/professionals/narcotic/electronic_prescribing/docs/2016-03-16_blanket_waiver_letter.pdf

https://www.health.ny.gov/professionals/narcotic/electronic_prescribing/docs/2016-03-16_blanket_waiver_letter.pdf

http://www.health.ny.gov/professionals/narcotic/laws_and_regulations/



excludes facsimiles from the definition of an electronic prescription. In order to be an acceptable prescription a facsimile must be issued on the Official New York State Prescription and contain a manual signature. In the event of a transmission failure, an intermediary may send a facsimile notification to the pharmacy. This notification will be for informational purposes only and is not considered a valid prescription.

Q14: I work for the Department of Veterans Affairs on federal property. Do I need to register my certified EPCS software application with BNE? A14: No, practitioners who practice on federal property do not fall under the jurisdiction of New York State. However, a practitioner working on federal property who also practices off of federal property within New York State, the EPCS software application that is used off of federal property must be registered with BNE. Q15: Can a practitioner who prescribes controlled substances electronically from multiple practice sites change the practice site address on the prescribing software or choose from multiple practices site addresses within the software to transmit the correct practice site address to the pharmacy?

A15: Practitioners should speak to their software vendor regarding the functionality around practice site addresses.

Q16: Will practitioners be required to issue electronic prescriptions for compounds containing a controlled substance ingredient as of March 27, 2016? A16: BNE is aware that there may be system limitations due to the NCPDP script standard. Please monitor BNE’s webpage for more information. Q17a: Will practitioners be required to electronically prescribe non-prescription items, including durable medical equipment? A17a: No, an electronic prescription will not be required. Section 281 (1) of the Public Health Law specifically references the use of electronic prescriptions for prescription drugs only. Q17b: If a third party payor requires a prescription for payment of non-prescription items, including durable medical equipment, can it be electronically prescribed? A17b: Consult with your electronic prescribing software vendor to ascertain if the e-prescribing software is capable of transmitting these items correctly. If not, a written ONYSRx, manually signed, is permissible. A “failover” electronic fax is never permissible. The only acceptable facsimile is a manually signed ONYSRx. Q18: Can an agent or employee of the prescriber create or prepare an electronic prescription? A18: Yes. Education law 6802 and Sections 80.67 and 80.69 of Title 10 NYCRR Part 80 do not prohibit an agent of the practitioner from preparing an electronic prescription for his or her review and electronic signature.



Q19: Can an agent or employee of the prescriber electronically sign an electronic prescription? A19: No. Practitioners are authorized to prescribe by virtue of his or her license to practice medicine or dentistry. Therefore, only the practitioner may review and sign the prescription. Q20: Can an agent or employee of the prescriber transmit an electronic prescription to the pharmacy? A20: The signing and transmission of an electronic prescription are two distinct actions. Only the practitioner may review and electronically sign the prescription. Once signed, an agent or employee of the practitioner may transmit the prescription on behalf of the practitioner. The act of transmission must be independent of the review and signature process. Q21: Can a Physician Assistant electronically prescribe controlled and non-controlled substances? A21: Yes. All electronic prescriptions issued and signed by a Physician Assistant must contain the name of their supervising physician. Q22: Is the supervising physician’s name required on an electronic prescription issued by a physician assistant? A22: Yes, the supervising physician’s name is required on all prescriptions (controlled and non-controlled substances) issued by a physician assistant, including electronic prescriptions, handwritten official prescriptions, and official prescriptions generated on an EMR system. Q23: Can a physician assistant register for EPCS if their supervising physician does not?

A23: Yes. The supervising physician is not required to register for EPCS if they have no intention of electronically prescribing controlled substances. Note: Both the supervising physician and physician assistant must maintain active registrations for the Official Prescription Program. Q24: Can an unlicensed resident, intern or foreign physician electronically prescribe controlled and non-controlled substances? A24: Yes. Please refer to 10 NYCRR 80.75 for further information. Q25: Is a resident, intern or foreign physician’s supervising physician/attending’s name or signature required to be on an electronic prescription?

A25: BNE does not require the supervising physician/attending’s name or signature to be on an electronic prescription, however third party payors or government programs may have additional requirements. Q26: Are residents, interns and foreign physicians required to provide their DEA suffix when prescribing electronically?

http://w3.health.state.ny.us/dbspace/NYCRR10.nsf/56cf2e25d626f9f785256538006c3ed7/8525652c00680c3e8525652c006f105e?OpenDocument&Highlight=0,Part,80



A26: Yes. 10NYCRR Part 80 §80.75(e) provides the authority for residents, interns and foreign physicians to use the DEA registration number of the institution by whom they are employed and they must include the suffix assigned by the institution to prescribe and dispense controlled substances (may be up to 21 characters). Q27: Is an attending physician that oversees residents, foreign physicians, and interns required to register for EPCS? A27: The attending physician is not required to register for EPCS if they have no intention of electronically prescribing controlled substances. Q28: Are unlicensed medical residents required to register their EPCS software with BNE? A28: No. The facility must maintain a current list of unlicensed residents with prescriptive privileges within the facility who have been authorized to access the facility’s EPCS software. This information must be available to BNE upon request. Q29: Does a practitioner still have to consult the Prescription Monitoring Program (PMP) Registry when e-prescribing?

A29: Yes. The practitioner must consult the PMP Registry prior to prescribing a controlled substance in Schedules II-IV regardless of how the prescription is issued. Q30: I am not licensed or practicing in New York, but have a patient who uses a pharmacy in New York. Do I have to register my certified EPCS software application with BNE to send electronic prescriptions for controlled substances to pharmacies in the state of New York?

A30: Practitioners who are not practicing in New York State are not required to register their certified EPCS software application with BNE. They must follow their state’s law and regulations.

Q31: Can I send an electronic prescription for a controlled substance to an out-of-state pharmacy?

A31: You may or may not be able to depending upon the laws of that state. The pharmacy must dispense the prescription following the laws of the state in which the prescription is being dispensed.

Q32: I don’t have a DEA number, therefore, I don’t prescribe controlled substances. Do I have to register the software application used to electronically prescribe non-controlled substances with BNE?

A32: There is no current requirement to register E-prescribing software applications that only transmit non-controlled substance prescriptions. However, all prescriptions must be issued electronically unless an exception applies. Q33: I am a veterinarian and would like to electronically prescribe controlled substances. What should I do?

A33: Practitioners issuing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification indicating that all federal requirements are met. The New York State Department of Health



requires practitioners licensed in New York State issuing electronic prescriptions for controlled substances to register their certified EPCS software application with BNE. Q34: Regulations (Title 10 NYCRR Part 80 §80.67(5) and §80.69(5)) state that the quantity of the dosage units must be indicated in both numerical and written word form on an Official New York State prescription (ONYSRx). Does this pertain to electronic prescriptions as well?

A34: No. While a quantity is required on all prescriptions, both the “numerical and written word form” are required to be on the ONYSRx form only. The intention of including both formats on the ONYSRx is to prevent alteration of the quantity on a written prescription.

Q35: Regulations (Title 10 NYCRR Part 80 §80.67 and §80.69 ) allow a practitioner to issue a prescription for greater than a 30 day supply of a controlled substance for certain conditions by specifying either the name of the condition, or the condition code, in accordance with codes designated in these sections, on the prescription. If no field for specifying the condition exists within the electronic prescribing application format, where should this be placed on an electronic prescription?

A35: A practitioner may use the notes field on the electronic prescription to indicate an approved condition or its corresponding code. A practitioner may also name the condition as part of the directions to the patient (sig. field).

Q36: Is the phrase “Authorization for Emergency Dispensing” required on the follow-up prescription for an emergency oral prescription for a schedule II controlled substance?

A36: Both 21 CFR Part 1300 §1306.11(d)(4) and New York Public Health Law Article 33 §3334(3) require the phrase “Authorization for Emergency Dispensing” on follow-up prescriptions for emergency oral prescriptions for Schedule II controlled substances. Q37: Does an electronic prescription for a controlled substance require a written follow-up prescription be sent to the pharmacy?

A37: No. The electronic prescription is the prescription and does NOT require a hard copy follow up prescription. Q38: Is it mandatory for pharmacies to receive electronic prescriptions for controlled substances?

A38: No. However, it will be mandatory for practitioners, with some exceptions, to issue electronic prescriptions for both controlled and non-controlled substances effective March 27, 2016. Q39: What are the practitioner and pharmacist responsibilities in the event of a transmission failure of an electronic prescription for a controlled substance?

A39: The responsibilities of the practitioner and the pharmacist with regard to failed transmission of an electronic controlled substance prescription may be found in detail in 10 NYCRR Part 80 Sections 80.67, 80.69, 80.73 and 80.74. Q40: What should I do if I am notified that the security of my certified EPCS software application is noncompliant with federal requirements?

http://w3.health.state.ny.us/dbspace/NYCRR10.nsf/56cf2e25d626f9f785256538006c3ed7/$searchForm?SearchView

http://w3.health.state.ny.us/dbspace/NYCRR10.nsf/56cf2e25d626f9f785256538006c3ed7/$searchForm?SearchView



A40: If your EPCS software application no longer meets federal security requirements, your software shall NOT be used to process electronic prescriptions for controlled substances until your software is in compliance with DEA requirements and you re-register the software application with BNE. Q41: What should I do if my credentials used to sign electronic prescriptions have been lost, stolen or compromised?

A41: In addition to any federal requirements, practitioners must immediately notify BNE that his or her credentials have been lost, stolen or compromised. Please send an email to [email protected] with the subject of credentials lost, stolen or compromised or call BNE’s toll free number (866-811-7957, Option 1).

Q42: What should I do if I suspect or am notified of a security breach with my certified EPCS software application?

A42: If there has been a security breach, you may not process electronic prescriptions for controlled substances. You must notify the DEA and BNE. After security has been restored, you must re-register the certified software application with BNE. Q43: What is the difference between the third party audit or certification required by the DEA and the registration that BNE requires?

A43: Practitioners and pharmacies processing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification indicating that all federal requirements are met. The New York State Department of Health does not certify software applications. However, practitioners and pharmacies licensed in New York State processing electronic prescriptions for controlled substances are required to register their certified EPCS software application with BNE. Q44: Why do I need to register my certified EPCS software application with the Bureau of Narcotic Enforcement (BNE)? My software vendor already notified BNE.

A44: Each individual practitioner and pharmacy, not the software vendor, is required by regulation to register their certified EPCS software application with BNE. Q45: My pharmacy is NOT physically located in New York, however, it is registered with the New York State Board of Pharmacy. Are we required to register our certified pharmacy software application with BNE to process electronic prescriptions for controlled substances received from practitioners in the state of New York?

A45: Yes, non-resident pharmacies registered with the New York State Board of Pharmacy must register their certified pharmacy software application with BNE to receive electronic prescriptions for controlled substances. Q46: My pharmacy is NOT located in New York. We are NOT registered with the New York State Board of Pharmacy. Do we have to register our certified pharmacy software application with BNE to process electronic prescriptions for controlled substances received from practitioners in the state of New York?

mailto:[email protected]



A46: No, pharmacies located outside of New York State that are NOT registered with the New York State Board of Pharmacy are not required to register their certified software applications with BNE. Q47: If a pharmacy does not dispense controlled substances, does their computer system have to be certified to meet the DEA security standards? A47: No. Computer systems only need to be certified that they meet the DEA security standards if they will be used to dispense controlled substances.

Q48: Can pharmacies receive electronic prescriptions for controlled substances from practitioners before it becomes mandated on March 27, 2016?

A48: Yes, EPCS became permissible in New York State on March 27, 2013. The pharmacy can receive electronic prescriptions for controlled substances provided that it has met the following requirements;

• The pharmacy software application meets all of the federal security requirements included in the DEA’s Interim Final Rule.

• The pharmacy can submit controlled substance prescription data to BNE using ASAP version 4.2. • The certified pharmacy software application is registered with BNE.

Q49: Can I accept an out-of-state electronic prescription for a controlled substance?

A49: A pharmacist may dispense a controlled substance medication pursuant to an out-of-state electronic prescription as defined in Section 80.78 Title 10 Part 80 Rules and Regulations on controlled substances. Electronic prescriptions may be created, signed and transmitted from another state, provided the practitioner complies with all requirements, state and federal, for issuing controlled substance prescriptions electronically. It is prudent on the part of the pharmacist to verify the authenticity of any controlled substance prescription presented to them.

Q50: Is the prescription valid for dispensing if the practitioner has not registered their certified EPCS application with BNE?

A50: Yes. The prescription is valid for dispensing if the practitioner has not registered their certified EPCS software application with BNE and the prescription meets all other federal and State requirements. Pharmacists are not expected to verify that a practitioner has registered their application with BNE. Q51: Can a pharmacy accept an electronic prescription as a follow-up to an oral prescription?

A51: Yes. A pharmacy may accept an electronic prescription as a follow-up to an oral prescription. It is incumbent on the pharmacist to know the limitations of their software application and if it can accurately accept and archive an electronic follow-up prescription. If the software application cannot do this, a paper prescription is necessary and permissible. This should be communicated to the practitioner at the time the prescription is called in, and the need for the follow-up is discussed. Q52: Certain elements may be changed or added to a controlled substance prescription by a pharmacist with practitioner authorization. If a prescription is sent electronically that requires information to be added or changed, how should the information be added to the electronic prescription?



A52: Information added/changed on an electronic prescription must be annotated and maintained electronically. Pharmacists should consult their software vendor or corporate headquarters for guidance to ensure annotation meets all federal requirements. The process of annotating a prescription may vary based on the software used. Q53: How does a pharmacist annotate an electronic prescription? A53: Pharmacists should consult their software vendor or corporate headquarters for guidance to ensure annotation meets all federal requirements. The process of annotating a prescription may vary based on the software used. Q54: Certain elements may NOT be changed or added to a controlled substance prescription. If a prescription is sent electronically that requires correction that cannot be made by a pharmacist with practitioner authorization, and the patient has an immediate need for the controlled substance, can the prescriber call in a 5 day emergency supply?

A54: In instances where the pharmacist may NOT add or change information, the pharmacist may use their professional judgment and call the practitioner to obtain an oral prescription, or request a new electronic prescription with the correct information after first canceling the incorrect original prescription. Click here for a reference regarding what a pharmacist may add/change on a controlled substance prescription.

Q55: Can a pharmacist add or clarify a condition code by calling the prescriber?

A55: Yes. The pharmacist shall write the date he or she received the oral authorization on the prescription and affix his or her signature. In the event of an electronic prescription, the pharmacist shall annotate and retain the same information in the electronic record. Q56: Can a pharmacist fill a prescription for a controlled substance that does not contain the maximum daily dose (MDD)?

A56: Pharmacists must exercise professional judgement when determining if clarification from the practitioner is necessary when a MDD is not included on a prescription. Pharmacists may call the practitioner and add the MDD to the prescription with practitioner authorization. However, omission of the MDD does not render the prescription invalid for dispensing. Q57: May a pharmacist accept an Official New York State Prescription written prior to March 27, 2016? A57: Yes. The prescription is written on an Official New York State Prescription form prior to the effective date of the statute. Q58: May a pharmacist dispense an authorized refill from an Official New York State Prescription issued prior to March 27, 2016? A58: Yes. The prescription, issued on an Official New York State Prescription form, with refills was written prior to the effective date of the statute.

http://www.health.ny.gov/publications/1086.pdf

http://www.health.ny.gov/publications/1086.pdf



Q59: Is a pharmacist who is presented with a prescription issued on Official New York State Prescription form after March 27, 2016 required to verify that the practitioner properly falls under one of the exceptions from the requirement to electronically prescribe? A59: No. However, a corresponding liability for the proper prescribing and dispensing of controlled substances rests with the pharmacist who fills the prescription.

Physician Assistant and Pharmacy EPCS Registration Form

Physician Assistant: Q60: How do I fill out the registration form?

A60: Complete all fields on the form. Incomplete forms will not be accepted by BNE. Below is a summary of each field and the information to be entered.

a. Practitioner Name: Enter your first and last name in this field. Please attach a list of your Supervising Physician(s) with their corresponding NYS license number and DEA registration number.

b. NYS License Number: Enter your six digit New York State license number (no prefix or suffix)

c. DEA Number for NYS: Enter each New York State DEA number that will be utilized to electronically prescribe controlled substances.

d. Practitioner Email Address: Enter the practitioner’s email address. e. Practitioner Telephone Number: Phone number of the practitioner. f. Name of Certified E-prescribing Software Application: Name of the application you are

using to electronically prescribe controlled substances. If you are not sure what the name of your software application is, contact your software application vendor.

g. Software Version Certified: Version number of the EPCS application. If you are not sure what version you are currently using, contact your software application vendor.

h. Name of Software Application Provider (Company Name): Name of the company (or corporation if you are not using a vendor) providing the certified EPCS software application.

i. Practitioner Signature: Signature of the practitioner. j. Date: Date that the form was signed by the practitioner. k. Print Name: The practitioner’s name should be printed in this field.

Q61: How often do I have to register my certified EPCS software application with BNE?

A61: The certified EPCS software application must be registered with BNE at least every two years or whenever the DEA requires a new third party audit of the software, whichever occurs first.

Q62: Can I register my certified EPCS software application before I’ve completed the identity proofing and obtained two-factor authentication? A62: No. Identity proofing must be completed and the practitioner must obtain two-factor authentication prior to registering the certified EPCS software application with BNE.



Q63: I work at more than one location and each location uses a different software application. Am I required to register each certified EPCS software application that I use?

A63: Yes, each different certified EPCS software application must be registered with BNE. If the same certified EPCS software application is used in multiple locations, then only one software application must be registered with BNE. Q64: Do you require a copy of the certification or third party audit to be submitted with the EPCS registration form?

A64: No, a copy of the certification or third party audit is not required with the registration. A copy must be available for inspection by the Department of Health if requested.

Q65: I am a Licensed Physician Assistant. Do I need to include my supervising physician’s name on the EPCS registration form?

A65: Yes. Please attach a list (excel file) of your Supervising Physician(s) with their corresponding NYS license number and DEA registration number with the signed EPCS registration form. A Licensed Physician Assistant issuing electronic prescriptions for controlled substances must comply with all requirements of Article 33 of the Public Health Law and Part 80 of Title 10 Part 80 Rules and Regulations on Controlled Substances.

Q66: How do I return the completed hard-copy EPCS registration form back to BNE?

A66: The completed form may be emailed to the BNE at [email protected] with EPCS Practitioner Registration in the subject line. Alternatively, the form may be faxed to BNE at 518-402-1058 or mailed to the following address:

Bureau of Narcotic Enforcement Riverview Center 150 Broadway Albany, NY 12204

Q67: Do I need to re-register if my certified EPCS software application version is upgraded?

A67: If you are notified of software version upgrades, you must re-register the new software version with BNE.

Q68: Do I need to re-register if I begin using a different certified EPCS software application?

A68: Yes, if you change to a new certified EPCS software application, you must register the new certified software application with BNE.

Q69: How do I know that the pharmacy has met the registration requirement with BNE?

A69: BNE does not publish a list of practitioners or pharmacies that have registered their certified EPCS software applications with BNE. It is the responsibility of the pharmacist to register their certified EPCS software application with BNE. BNE will follow-up with pharmacies who have not registered.




Q70: I received a certification from my intermediary (Surescripts or other provider). If I have this certification, can I register my application with BNE? A70: Practitioners issuing electronic prescriptions for controlled substances must use a software application that meets all DEA (federal) security requirements, which includes a third party audit or DEA certification, not an intermediary certification, indicating that all federal requirements are met. The New York State Department of Health requires practitioners licensed in New York State issuing electronic prescriptions for controlled substances to register their certified EPCS software application with BNE. Q71: Now that I have registered my EPCS software with BNE and have received registration confirmation from BNE, can I electronically prescribe? A71: Yes, provided that your EPCS system and prescription meets all federal and state requirements.

Pharmacy: Q72: How do I fill out the registration form?

A72: Complete all fields on the form. Incomplete forms will not be accepted by BNE. Below is a summary of each field and the information to be entered.

a. Pharmacy Name: Enter the pharmacy name corresponding to the pharmacy NCPDP/NABP name in the Pharmacy Name field.

b. NCPDP/NABP: Enter the pharmacy NCPDP/NABP number in the NCPDP/NABP field. For chain pharmacies, please attach a list of NCPDP/NABP numbers with the corresponding NYS license number for those stores utilizing the certified pharmacy software application.

c. NYS License Number: Enter the pharmacy license number. d. ASAP Version for Data Submissions: Enter the version number for the American Society

for Automation in Pharmacy (ASAP) standard used for data submissions. In order to receive electronic prescriptions for controlled substances, data submissions must be in ASAP Version 4.2 or greater. If you are unsure what version the pharmacy is using for data submissions, please contact your software vendor.

e. Contact Name: Individual responsible for answering questions about this registration. f. Contact Email Address: Email address of the individual responsible for answering

questions about the pharmacy’s registration. g. Contact Phone: Phone number of the individual responsible for answering questions

about the pharmacy’s registration. h. Name of Certified Pharmacy Software Application: Name of the pharmacy application

used to dispense prescriptions. If you are not sure what the name of your pharmacy software application is, contact your pharmacy software application vendor.

i. Software Version Certified: Version number of the pharmacy application used to dispense prescriptions. If you are not sure what version you are currently using, contact your pharmacy software application vendor.



j. Name of Software Application Provider (Company Name): Name of the company (or corporation if you are not using a vendor) providing the pharmacy software application.

k. Signature: Signature of the person authorized to sign the registration form on behalf of the pharmacy.

l. Date: Date that the form was signed by the authorized person. m. Print Name: Name of the authorized person. n. Title: Title of the authorized person signing the form.

Q73: How often do I have to register my certified pharmacy software application with BNE?

A73: The certified pharmacy software application must be registered with BNE at least every two years or whenever functionality related to controlled substance prescription requirements is altered, whichever occurs first. Q74: I work for a chain pharmacy. Do I have to register the certified pharmacy software application with BNE?

A74: Chain pharmacy corporate headquarters may submit one form to register all of their pharmacies with BNE. If a corporation is registering all stores, each NCPDP/NABP number, NYS license number and corresponding NYS license number must be provided in a separate attachment (excel file) with the signed registration form. If you are not sure whether or not your pharmacy was registered, please contact your corporate headquarters.

Q75: What should the chain corporate headquarters include with the registration form?

A75: Each NCPDP/NABP number, NYS license number and corresponding store number must be provided in a separate attachment (excel file) with the signed registration form. Q76: Do you require a copy of the certification or third party audit to be submitted with the EPCS registration form? A76: A copy of the certification or third party audit is not required with the registration. A copy of your certification or third party audit must be available for inspection by the Department of Health, if requested.

Q77: Do I have to mail the hard-copy form back to BNE?

A77: The completed form may be emailed to the BNE at [email protected] with EPCS Pharmacy Registration in the subject line. Alternatively, the form may be faxed to BNE at 518-402-0709 or mailed to the following address:

Bureau of Narcotic Enforcement Riverview Center 150 Broadway Albany, NY 12204

Q78: When will you notify me that it is okay to receive electronic prescriptions?




A78: The pharmacy/corporate headquarters will receive an email from BNE once registration requirements are met. Q79: Do I need to re-register if my pharmacy software application version is upgraded?

A79: If you are notified of software version upgrades pertaining to controlled substance functionality, you must re-register with BNE.

Q80: Do I need to re-register if my pharmacy software application changes?

A80: If you switch to a new software application, you must re-register with BNE.

Q81: In order to fill an electronic prescription for a controlled substance, do I need to verify that the practitioner has registered with BNE?

A81: No. BNE does not publish a list of practitioners or pharmacies who have registered their certified EPCS software applications with BNE. It is the responsibility of the practitioner to register their certified EPCS software application with BNE. BNE will follow-up with practitioners who have not registered. Q82: Now that I have registered my pharmacy software with BNE and have received registration confirmation from BNE, can I receive electronic prescriptions for controlled substances? A82: Yes, provided that your EPCS system and the prescription meet all federal and state requirements. Controlled substance prescription data submissions to BNE must be in ASAP Version 4.2 and include the following information:

• The State Issued Rx Serial Number field (AIR02) must be populated with the letter E eight times (EEEEEEEE).

• The Electronic Prescription Reference Number field (DSP20) must be populated. • The Electronic Prescription Order Number field (DSP21) must be populated.

Additional information can be found in the Submitter’s Guide to Electronic Data Transmission for the New York State PMP, which can be accessed through the following link: http://www.health.ny.gov/professionals/narcotic/electronic_data_transmission/docs/submitter_guide.pdf

ROPES for Practitioners and Institutions

Practitioner: Q83: What does ROPES stand for? A83: ROPES stands for: Registration for Official Prescriptions and E-Prescribing Systems.

Q84: What is the purpose of the ROPES application?

http://www.health.ny.gov/professionals/narcotic/electronic_data_transmission/docs/submitter_guide.pdf



A84: The ROPES application will allow practitioners to update/certify/renew their Official Prescription Program (OPP) registration and to register or modify their certified electronic prescribing software application for controlled substances (EPCS software) at the same time.

Q85: Who can access ROPES? A85: ONLY practitioners can access this application. No one else can do this on their behalf.

Q86: How does a practitioner access ROPES? A86: To access ROPES, use the following steps:

• Login to the Health Commerce System (HCS) at https://commerce.health.state.ny.us • Under “My Content” click on “All Applications” • Click on “R” • Scroll down to ROPES and double click to open the application. You may also click on the

“+” sign to add the application “ROPES” under “My Applications” on the left side of the screen.

Q87: Can all practitioners utilize ROPES? A87: Access to ROPES is ONLY for those practitioners who:

• Have already registered with the Official Prescription Program (OPP) and • Have an active DEA registration and • Have an active NYS license and • Are not a Registered Physician Assistant (PA)

Q88: Can a PA access ROPES? A88: No. PA’s must continue to submit the OPP Registration form (DOH-4329) along with the PA Authorization Form (DOH-5054) to renew their OPP registration.

Q89: Can a practitioner without a Drug Enforcement Administration (DEA) registration number access ROPES? A89: No. Practitioners without a DEA registration must continue to submit a notarized OPP Registration form (DOH-4329) to renew their OPP registration.

Q90: Can a practitioner who is not registered with OPP access ROPES? A90: No. Practitioners not already registered with OPP will be directed to complete the OPP Registration form (DOH-4329) first and submit it to the Bureau of Narcotic Enforcement (BNE). Once this is entered by BNE staff, the practitioner will be able to access ROPES.

Q91: Can a practitioner register their EPCS software without renewing their OPP registration? A91: No. Practitioners who need to register or modify their certified EPCS software application(s) will be required to update/certify their OPP registration information on file with the NYS BNE first.



Please note: The renewal of the OPP registration is an easy one step process and it extends the renewal date for another 2 years.

Q92: What is ROPES used for? A92: ROPES will allow practitioners to:

• renew OPP registration, or • renew OPP registration and register /modify EPCS software

NOTE: Practitioners cannot register or modify their current EPCS registration information without first renewing their OPP registration each time. The renewal of the OPP registration is an easy one step process.

Q93: If a practitioner recently renewed their OPP registration using the DOH-4329 form, is an electronic renewal still required prior to registering EPCS software? A93: Yes. The practitioner will be required to renew his/her OPP registration again on-line before registering their EPCS software within ROPES. Q94: If a practitioner recently renewed their OPP registration using the DOH-4329 form and is not registering their EPCS software, is an electronic renewal required as well? A94: No.

Q95: What information can a practitioner change or update on an OPP renewal in ROPES? A95: Practitioners are only allowed to enter/change their NPI number when accessing the OPP registration data. All other fields are “Read only”. Q96: How does a practitioner update inaccurate information that is displayed in ROPES pertaining to their address, NYS license or DEA registration? A96: Practitioners are directed to contact the DEA at 877-883-5789 to correct any inaccuracies with their address and DEA registration. For errors with their NYS license, practitioners should contact the State Education Department at 518-474-3817, ext. 150. If you have additional questions or comments regarding your OPP registration information, please email [email protected] or call 1-866-811- 7957 (Option 1) and ask for the OPP Registration Unit. Q97: Is the OPP registration still valid for 2 years? A97: Yes. The OPP registration is valid from the renewal date regardless of whether using the OPP Registration form (DOH-4329) or ROPES. Q98: What information is required from a practitioner to register the certified EPCS software application(s) in ROPES?




A98: Practitioners must provide the following information: • practitioner email address • practitioner telephone number • name of the company providing the certified EPCS software application • name of the certified EPCS software application • version number of the certified EPCS software application

Q99: Can a practitioner remove EPCS software previously registered in ROPES that he/she is no longer using? A99: Yes. The ROPES application provides the ability to remove a certified EPCS software application by checking the “Remove” box provided on the EPCS Registration screen. Q100: Is there a limit on the number of certified EPCS software applications that can be registered by a practitioner in ROPES? A100: No. The practitioner can register as many EPCS software applications as applicable.

Institution (i.e. hospital, nursing home, etc): Q101: What does ROPES stand for? A101: ROPES stands for: Registration for Official Prescriptions and E-Prescribing Systems.

Q102: What is the purpose of the ROPES application? A102: The ROPES application will allow a facility to renew its Official Prescription Program (OPP)

registration and to ANNUALLY register or modify its certified electronic prescribing software application for controlled substances (EPCS software).

Q103: Are there different applications for individual practitioners and healthcare facilities? A103: Individual practitioners and healthcare facilities would both access the same online application,

ROPES, to renew the registration for OPP and to register the certified EPCS software. The first screen should display information for the healthcare facility or the individual practitioner depending on the individual logging in to HCS.

Please note that the practitioner can either register the software used at the healthcare facility

or the healthcare facility can register the software used by that practitioner at the healthcare facility. Only one registration is necessary.

Q104: Who can access ROPES for facilities? A104: ONLY Health Commerce System (HCS) Coordinators for the facility can access this application.

Q105: How does a HCS Coordinator for the facility access ROPES?



A105: To access ROPES, use the following steps:

• Login to the Health Commerce System (HCS) at https://commerce.health.state.ny.us • Under “My Content” click on “All Applications” • Click on “R” • Scroll down to ROPES and double click to open the application. You may also click on the

“+” sign to add the application “ROPES” under “My Applications” on the left side of the screen.

Q106: How does a healthcare facility find out who is the HCS Coordinator for the healthcare facility? A106: Please contact the Commerce Account Management Unit (CAMU) at 866-529-1890. A

representative should be able to assist you. Q107: Can all facilities utilize ROPES? A107: Access to ROPES is ONLY for healthcare facilities who:

• Have already registered with the Official Prescription Program (OPP) and • Have an active Class 3 or Class 3A NYS controlled substance license

Q108: Does a facility need to register for OPP and EPCS for each BNE controlled substance license

number? A108: Yes. Separate registrations must be completed. And, a Comma-Separated-Values (CSV) file must

be uploaded annually for each BNE controlled substance license number to complete the facility EPCS registration process.

Q109: How long is the facility EPCS registration valid? A109: The facility EPCS registration is valid for ONE YEAR. A CSV file containing the facility’s current

certified EPCS software application(s) and the practitioners authorized to access the facility’s certified EPCS software application(s) must be uploaded at least once per year. In addition, each time the EPCS functionality of the software application(s) is modified, the facility must re-register the certified EPCS software.

Q110: What information is required from a facility to register the certified EPCS software application(s)

in ROPES? A110: Healthcare facilities must provide the following information:

• facility contact name • facility contact email address • facility contact telephone number • practitioner’s NYS DEA registration number (not a facility DEA registration number) • name of the company providing the certified EPCS software application • name of the certified EPCS software application • version number of the certified EPCS software application



Please Note: The facility can include Physician Assistants authorized to access the facility’s certified EPCS software on the CSV file.

Q111: Should a practitioner be listed multiple times on the CSV file if he/she uses multiple certified

facility EPCS software applications? A111: Yes. The practitioner should be listed for each EPCS software application. Q112: Should the facility include unlicensed residents/interns/foreign physicians on the CSV file? A112: No. Information regarding unlicensed residents/interns/foreign physicians authorized to access

the facility’s certified EPCS software must be maintained by the facility and be available upon request.

Q113: Can a facility remove EPCS software previously registered in ROPES that is no longer being used

at the facility? A113: Yes. The ROPES application allows the facility to upload a new CSV file anytime. The new file will

overwrite ALL of the information contained on the previous file, therefore, include all current registrants and software applications on your new file.

Q114: Is there a limit on the number of certified EPCS software applications that can be registered by

a facility in ROPES? A114: No. The facility can register as many EPCS software applications as applicable. Q115: If there are errors on the CSV file, will the facility EPCS registration be complete? A115: No. The CSV file must be uploaded without errors in order to complete the facility EPCS

registration. Q116: The file upload was successful, but all the practitioners and EPCS software applications listed on

the file was not uploaded. Please explain. A116: The practitioner and corresponding EPCS software Information will not be registered for

practitioners with a DEA registration number on the CSV file that is: • Invalid; • Non-NYS DEA registration number; or • A facility DEA registration number.

Q117: Can a facility that is not registered with OPP access ROPES?



A117: No. Healthcare facilities not already registered with OPP should contact the Bureau of Narcotic Enforcement (BNE) at 866-811-7957, Option 1 and request a Facility Registration Form. Once this is entered by BNE staff, the facility representative will be able to access ROPES.

Q118: Can a facility register their EPCS software without renewing their OPP registration? A118: No. Healthcare facilities who need to register or modify their facility’s certified EPCS software

application(s) will be required to update/certify the OPP facility registration information on file with the NYS BNE first.

Please note: The renewal of the OPP registration is an easy one step process. Q119: What is ROPES used for? A119: ROPES will allow healthcare facilities with an active Class 3 or Class 3A NYS controlled substance license to:

• renew OPP facility registration, or • renew OPP facility registration and register /modify the facility’s EPCS software and

practitioners authorized to access the facility’s EPCS software

NOTE: Healthcare facilities cannot register or modify their current EPCS registration information without first renewing their OPP registration each time. The renewal of the OPP registration is an easy one step process.

Q120: What information can a facility change or update on an OPP renewal in ROPES? A120: Healthcare facilities are not allowed to enter/change the OPP registration data. All fields are

“Read Only”. Q121: How does a facility update inaccurate address information that is displayed in ROPES? A121: Questions regarding the OPP facility registration information should be sent to

[email protected] or call 1-866-811-7957 (Option 1) and ask for the OPP Registration Unit.

Software and Data Requirements Q122: Does BNE provide EPCS software?

A122: No. BNE does not provide software for practitioners or pharmacies to use. Q123: Where do I find the software that will allow a practitioner to electronically prescribe controlled substances? A123: BNE does not endorse a specific EPCS software for practitioners to use. You may research different options on the internet, speak to your professional colleagues or professional associations that




you are associated with to determine what options are available. You may also wish to contact your current Electronic Health Record (EHR) software application provider, if you are currently using EHR. Q124: How do I know if my software has been certified to process electronic prescriptions for controlled substances? A124: Please contact your software vendor, they should be able to provide you with this information. Q125: Are additional fields required by BNE on the submission of controlled substance data from electronic prescriptions? A125: Controlled substance prescription data submissions to BNE must be in ASAP Version 4.2 and include the following information:

• The State Issued Rx Serial Number field (AIR02) must be populated with the letter E eight times (EEEEEEEE).

• The Electronic Prescription Reference Number field (DSP20) must be populated. • The Electronic Prescription Order Number field (DSP21) must be populated.

Additional information can be found in the Submitter’s Guide to Electronic Data Transmission for the New York State PMP, which can be accessed through the following link: http://www.health.ny.gov/professionals/narcotic/electronic_data_transmission/docs/submitter_guide.pdf

Waivers and Exceptions NOTE: The following applies to practitioners only! A pharmacist is NOT required to verify that a practitioner properly falls under one of the exceptions from the requirement to electronically prescribe. Pharmacists may continue to dispense medications from valid written, oral, or fax prescriptions that are consistent with current laws and regulations. Q126: Are any specific specialties or fields excluded from the requirement to electronically prescribe prescriptions? A126: Only veterinarians are excluded by nature of their license. All other practitioners are required to issue electronic prescriptions unless granted a waiver or meeting one of the limited situational exceptions. In addition, practitioners who are not veterinarians may be excluded if they meet the criteria defined within Article 2A Section 281 of the Public Health Law and Section 80.64 Title 10 Part 80 Rules and Regulations on Controlled Substances. Please review this section of the law and regulations, which may be accessed from the following links: Article 2A - Section 281 and Title 10 Part 80 Section 80.64 Q127: What exceptions are there from the requirement to electronically prescribe? A127: The following is a list of exceptions from the requirement to electronically prescribe and may be accessed from the following link: Article 2A - Section 281.

http://www.health.ny.gov/professionals/narcotic/electronic_data_transmission/docs/submitter_guide.pdf


http://w3.health.state.ny.us/dbspace/NYCRR10.nsf/56cf2e25d626f9f785256538006c3ed7/8525652c00680c3e8525652c006f1632?OpenDocument&Highlight=0,80.64




• Prescriptions issued by veterinarians • Prescriptions issued in circumstances where electronic prescribing is not available due to

temporary technological or electrical failure • Prescriptions issued by a practitioner under circumstances where the practitioner reasonably

determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition. In addition to these circumstances, the quantity of controlled substances cannot exceed a five day supply if the controlled substance were used in accordance with the directions for use.

• Prescriptions issued by a practitioner to be dispensed by a pharmacy located outside the state. • Practitioners who have received a waiver or a renewal thereof for a specified period determined

by the commissioner, from the requirement to use electronic prescribing.

Q128: Are oral (phone in, verbal) prescriptions still permissible after the e-prescribing mandate becomes effective? A128: Yes, only if one of the following circumstances apply

• Temporary power outage • Temporary technical failure • Practitioner has a waiver • Practitioner is a Veterinarian • Practitioner is out of state • Practitioner reasonably determines that it would be impractical for the patient to obtain

substances prescribed by electronic prescription in a timely manner and such delay would adversely impact the patient’s medical condition, provided that if such prescription is for a controlled substance, the quantity of controlled substances does not exceed a 5 day supply.

Q129: Are Official New York State Prescription forms still permissible after the e-prescribing mandate becomes effective? A129: Yes, only if one of the following circumstances apply

• Temporary power outage • Temporary technical failure • Practitioner has a waiver • Practitioner is a Veterinarian • Pharmacy is located out of state • Practitioner reasonably determines that it would be impractical for the patient to obtain

substances prescribed by electronic prescription in a timely manner and such delay would adversely impact the patient’s medical condition, provided that if such prescription is for a controlled substance, the quantity of controlled substances does not exceed a 5 day supply.

Q130: What is the procedure to notify the Bureau when using an exception to electronic prescribing? A130: The mandate to electronically prescribe has been extended until March 27, 2016. Continue to monitor our website.



Q131: Can practitioners apply for a waiver from the requirement to electronically prescribe? A131: The Prescription Drug Reform act- Chapter 447 of the laws of 2012 and Title 10 Part 80 of the Official Compilation of Codes, Rules and Regulations of the State of New York (§80.64(c)(3)) allows the Commissioner of Health to grant a practitioner a waiver, not to exceed a time period of one year, from the requirement to electronically prescribe. Waivers may be granted based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner.

Q132: I already have a waiver from the requirement to consult the Prescription Monitoring Program Registry. Am I exempt from electronic prescribing since I have this waiver? A132: No. A separate waiver is required. The Prescription Drug Reform act- Chapter 447 of the laws of 2012 and Title 10 Part 80 of the Official Compilation of Codes, Rules and Regulations of the State of New York (§80.64(c)(3)) allows the Commissioner of Health to grant a practitioner a waiver, not to exceed a time period of one year, from the requirement to electronically prescribe. Waivers may be granted based upon a showing of economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner.

Online Electronic Prescribing Waiver Requests (EPW) Single Practitioners: Q133: How do I submit a waiver request from electronic prescribing as a single practitioner? A133:

Online Electronic Prescribing Waiver Request Process – Single Practitioner

Complete the steps below to access the Electronic Prescribing Waiver (EPW) application in the NYS Health Commerce System (HCS): 1. Log into the HCS at https://commerce.health.state.ny.us 2. Under “My Content” click on “All Applications” 3. Click on “E” 4. Scroll down to Electronic Prescribing Waivers and double click to open the application. You may also

click on the “+” sign to add this application under “My Applications” on the left side of the Home screen.

https://commerce.health.state.ny.us/



Complete the steps below to request a waiver within the EPW application for the first time: 1. Select the practitioner name from the list. If the name appears more than once, select the

option that starts with the profession (i.e., Medicine-###### Doe John). If you are affiliated with a medical group practice or institution refer to the appropriate instructions for that requestor type.

2. Provide contact information for the person who should be contacted if additional information is

needed regarding the waiver request and click “Save”.



3. On the “Waiver Requests Summary” screen click on “Create Waiver Request for Self”. If you need to create a waiver request for multiple practitioners, click on “Create Waiver Request for Multiple Practitioners” and follow the instructions for a Medical Group Practice request.



4. Search for the Official NYS Prescription (OPP) shipping address for the site requiring a waiver. The requestor can search by the following options:

1. The NYS License Number of the practitioner requesting the waiver This option is recommended if requesting a waiver for your private practice site.

2. Enter the DOH Article 33 License Number (030####, 03A####, 03B####) This option is recommended if requesting a waiver for an institution site where you use the institution’s prescription forms.

3. Enter an OPP serial number from a prescription form used at the site requiring a waiver Use this option only if you cannot identify the OPP shipping address from Options 1 or 2.



5. Select the OPP shipping address from the list returned and click “Create Waiver Request”. Please note: Only active OPP shipping addresses will be displayed; i.e., the practitioner or institution is currently registered with the Official NYS Prescription Program. Additional OPP shipping addresses will require separate waiver requests and can be initiated at the completion of this waiver request, if needed.



6. After selecting the OPP shipping address, the “Waiver Request” screen will display (below). On this screen, you will provide additional information required to complete the waiver request: the waiver site address(es), the Rx type(s), reason(s) for the waiver and supporting documentation.



7. Indicate the waiver site address(es) for this request. If the waiver site is an institution, the waiver site address will default to the OPP shipping address. If the waiver site is a Private Practice, the requestor must indicate if the OPP shipping address should be included as a waiver site by clicking on the link “Include OPP Shipping Address as a Waiver Site”. In addition, a practitioner can add waiver site addresses associated with the OPP shipping address, if necessary, by clicking on the link “Add New Address”. Enter in the address information and click “Save”.

8. Select the type of prescription for which a waiver is required (check all that apply) 9. Select the reason for the waiver (check all that apply)



10. Provide documentation in support of the need for a waiver by entering the justification in the box provided AND/OR uploading a supporting document(s) by clicking on the link “Upload Supporting Document”.

11. Verify that all information, including ALL waiver site addresses, is complete and accurate. 12. Select “Submit Waiver Request” at the bottom of the screen if all of the information is complete and

accurate. Select “Save for Later” if additional information is required.



13. If all of the requirements to submit a waiver request are checked, click on the button “Attest/Submit Waiver Request”. If one or more of the requirements are unchecked, click on the button “Back to Request Screen” and complete the missing requirements.



14. Once the request has been submitted, a confirmation message will display on the Waiver Request Summary screen. The waiver request status will be marked as “Under Review”.

15. Click on “Create Waiver Request for Self” or “Create Waiver Request for Multiple Practitioners” if

the requestor needs to request a waiver for another site associated with a different OPP shipping address.

16. The “Waiver Requests Summary” screen will reflect the current status of each waiver request, including approval and denial. Practitioners should monitor the status of each waiver request via the EPW application.



Medical Group Practice: Q134: How do I submit a waiver request from electronic prescribing as a medical group practice? A134: Online Electronic Prescribing Waiver Request Process - Medical Group Practice

(Two or more practitioners)

Can be completed by a licensed practitioner or staff with either one of the following roles: 1. HCS Coordinator 2. Electronic Prescribing Waivers (EPW) Requestor

Complete the steps below to access the Electronic Prescribing Waiver (EPW) application in the NYS Health Commerce System (HCS): 1. Log into the HCS at https://commerce.health.state.ny.us 2. Under “My Content” click on “All Applications” 3. Click on “E” 4. Scroll down to Electronic Prescribing Waivers and double click to open the application. You may also





Complete the steps below to request a waiver within the EPW application for the first time: 1. Select the Medical Group Practice that is requesting the waiver. If the medical group practice name

is not displayed, then select the practitioner name from the list that starts with the profession (i.e., Medicine-###### Doe John).

2. Provide contact information for the person who should be contacted if additional information is

needed regarding the waiver request and click “Save”.



3a. If the Medical Group Practice is selected in Step 1, on the “Waiver Requests Summary” screen click on “Create Waiver Request” and proceed to Step 4.

3b. If the Practitioner name is selected in Step 1, on the “Waiver Requests Summary” screen click on

“Create Waiver Request for Multiple Practitioners” and proceed to Step 4.




1. Upload the Practitioner License List (CSV file)

This option is recommended if requesting a waiver for your medical group practice site. 2. Enter the DOH Article 33 License Number (030####, 03A####, 03B####)

Medical Group Practices Do Not Use - This option is for institutions only 3. Enter an OPP serial number from a prescription form used at the site requiring a waiver

Use this option only if you cannot identify your OPP shipping address from Option 1.



5. Select the OPP shipping address from the list returned and click “Create Waiver Request”. Please note: Only active OPP shipping addresses will be displayed; i.e., the practitioner is currently registered with the Official NYS Prescription Program. Additional OPP shipping addresses will require separate waiver requests and can be initiated at the completion of this waiver request, if needed.



6. After selecting the OPP shipping address, the “Waiver Request” screen will display (see below). On this screen, you will provide additional information required to complete the waiver request: the waiver site address(es), the Rx type(s), reason(s) for the waiver, uploading a file of the practitioners included in this request, supporting documentation and uploading a file of the practitioner attestations.



7. The requestor must indicate if the OPP shipping address should be included as a waiver site by clicking on the link “Include OPP Shipping Address as a Waiver Site”. In addition, a medical group practice can add up to 3 additional waiver site addresses associated with the OPP shipping address, if necessary, by clicking on the link “Add New Address”.

8. If not already completed in Step 4, upload the comma-separated-values (CSV) file listing the

practitioners included in the waiver request by clicking on the link “Upload Practitioner Licenses”. Please note: Only practitioners with a valid NYS license (##, ######) will be loaded. Each CSV file will replace the prior file that was uploaded.




11. Provide documentation in support of the need for a waiver by entering the justification in the box

provided and/or uploading a supporting document(s) by clicking on the link “Upload Supporting Document”.

12. Upload the signed practitioner attestations file(s) by clicking on the link “Upload Attestation

Document”.



13. Verify that all information, including ALL waiver site addresses, is complete and accurate. 14. Select “Submit Waiver Request” at the bottom of the screen if all of the information is complete and





17. Click on “Create Waiver Request” if the requestor needs to request a waiver for another site

associated with a different OPP shipping address. 18. The “Waiver Requests Summary” screen will reflect the current status of each waiver request,

including approval and denial. Medical Group Practices and Practitioners should monitor the status of each waiver request via the EPW application.



Institutions: Q135: How do I submit a waiver request from electronic prescribing as an institution? A135:

Online Electronic Prescribing Waiver Request Process - Institution

Can be completed by institution staff with either one of the following roles:

3. HCS Coordinator 4. Electronic Prescribing Waivers (EPW) Requestor

Complete the steps below to access the Electronic Prescribing Waiver (EPW) application in the NYS Health Commerce System (HCS):

1. Log into the HCS at https://commerce.health.state.ny.us

2. Under “My Content” click on “All Applications”

3. Click on “E”

4. Scroll down to Electronic Prescribing Waivers and double click to open the application. You may also click on the “+” sign to add this application under “My Applications” on the left side of the Home screen.




Complete the steps below to request a waiver within the EPW application for the first time:

1. Select the Institution that is requesting the waiver.



2. Provide contact information for the person who should be contacted if additional information is needed regarding the waiver request and click “Save”.

3. On the “Waiver Requests Summary” screen click on “Create Waiver Request”




1. Upload the Practitioner License List (CSV file) This option is recommended if requesting a waiver for a medical group practice site.

2. Enter in the DOH Article 33 License Number (030####, 03A####, 03B####). This option is recommended if requesting a waiver for a site listed on the Operating Certificate.

3. Enter an OPP serial number from a prescription form used at the site requiring a waiver. Use this option only if you cannot identify the OPP shipping address from options 1 or 2.



5. Select the OPP shipping address from the list returned and click “Create Waiver Request”. Please note: Only active OPP shipping addresses will be displayed; i.e., the practitioner or institution is currently registered with the Official NYS Prescription Program. Additional OPP shipping addresses will require separate waiver requests and can be initiated at the completion of this waiver request, if needed.



6. After selecting the OPP shipping address, the “Waiver Request” screen will display (see below). On this screen, you will provide additional information required to complete the waiver request: the waiver site address(es), the Rx type(s), reason(s) for the waiver, uploading a file of the practitioners included in this request, supporting documentation and uploading a file of the practitioner attestations.



7. If the waiver site is an institution, the waiver site address will default to the OPP shipping address. If the waiver site is a Medical Group Practice, the requestor must indicate if the OPP shipping address should be included as a waiver site by clicking on the link “Include OPP Shipping Address as a Waiver Site”. In addition, a medical group practice can add up to 3 additional waiver site addresses associated with the OPP shipping address, if necessary, by clicking on the link “Add New Address”. Please indicate if the OPP shipping address should be included Enter in the address information and click “Save”.

8. If not already completed in Step 4, upload the comma-separated-values (CSV) file listing the practitioners included in the waiver request by clicking on the link “Upload Practitioner Licenses”. Please note: Only practitioners with a valid NYS license (##, ######) will be loaded. Each CSV file will replace the prior file that was uploaded.




11. Provide documentation in support of the need for a waiver by entering the justification in the box provided and/or uploading a supporting document(s) by clicking on the link “Upload Supporting Document”.



12. Upload the signed practitioner attestations file(s) by clicking on the link “Upload Attestation Document”.

13. Verify that all information is complete and accurate. 14. Select “Submit Waiver Request” at the bottom of the screen if all of the information is complete and





17. Click on “Create Waiver Request” if the requestor needs to request a waiver for another site associated with a different OPP shipping address.

18. The “Waiver Requests Summary” screen will reflect the current status of each waiver request, including approval and denial. Institutions should monitor the status of each waiver request via the EPW application.



Practitioner Reporting Requirement Q136: Is the practitioner required to notify the Department when an ONYSRx or oral prescription is issued under one of the exceptions to electronic prescribing? A136: No. Effective September 30, 2016 the NYS Public Health Law was amended and no longer requires that practitioners notify the Department of Health when using an exception to the e-prescribing mandate. Q137: What is a practitioner required to do when an ONYSRx or oral prescription was issued under one of the exceptions to electronic prescribing? A137: Practitioners must indicate in the patient’s health record that an exception was used. Q138: Is a practitioner still required to send an email to [email protected] even though a notation is indicated in the patient’s health record? A138: No. Q139: When an ONYSRx or oral prescription was issued under one of the exceptions to electronic prescribing what information needs to be included in the patient health record? A139: The practitioner should indicate the reason(s) for only the following 3 exception(s) in the patient’s health record. These are: electronic prescribing is not available due to temporary technological or electrical failure,

issued by a practitioner under circumstances where, notwithstanding the practitioner's present

ability to make an electronic prescription, such practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition,

issued by a practitioner to be dispensed by a pharmacy located outside the state.

Q140: Where can the exceptions that must be indicated in the patient record be found in public health law? A140: PHL Sections 281(3) (b), (d), and (e) indicates the following exception requirements: issued in circumstances where electronic prescribing is not available due to temporary

technological or electrical failure, issued by a practitioner under circumstances where, notwithstanding the practitioner's present

ability to make an electronic prescription, such practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the patient's medical condition,

issued by a practitioner to be dispensed by a pharmacy located outside the state.




Q141: If a practitioner is approved for a waiver from electronic prescribing, are they required to indicate in the patient’s health record that an ONYSRx or oral prescription was issued? A141: No. Q142: If a practitioner practicing at a nursing home/residential health care facility has a blanket waiver signed by the Commissioner of Health on March 16, 2016, is the practitioner required to indicate in the patient’s health record that an ONYSRx or oral prescription was issued? A142: No. Q143: If a practitioner issues an ONYSRx or oral prescription to be dispensed outside of New York State is the practitioner required to indicate the reason in the patient’s health record? A143: Yes. Q144: If a practitioner experiences a temporary technical failure with the electronic prescribing software and issues an ONYSRx or oral prescription, are they required to indicate the reason in the patient’s health record? A144: Yes. Q145: If a practitioner experiences a temporary electronic failure and issues an ONYSRx or oral prescription, are they required to indicate the reason in the patient’s health record? A145: Yes.

Certifications Q146: How does a practitioner certify that he or she will not issue more than 25 prescriptions during a twelve-month period? A146: A practitioner can either submit a certification online through the Electronic Prescribing Waiver (EPW) application on the NYS Health Commerce System or by submitting Certification form, DOH-5221, to the Bureau of Narcotic Enforcement. Complete the steps below to submit a certification online in HCS:

1. Log into the HCS at https://commerce.health.state.ny.us 2. Under “My Content” click on “All Applications” 3. Click on “E” 4. Scroll down to Electronic Prescribing Waivers and double click to open the application. You may also




5. Select the practitioner name from the list. If the name appears more than once, select the option that starts with the profession (i.e., Medicine-###### Doe John).

6. Provide contact information for the person who should be contacted regarding the Certification. 7. Click on “Submit Certification” 8. Enter in the “Begin Date” of the twelve-month certification period. 9. Enter in the Mailing Address of the practitioner submitting the certification. 10. Click “Submit” 11. Click “Certify” 12. You will be returned to the “Waiver Requests and Certifications Summary” screen. The certification

period will be displayed. Q147: Can a practitioner submit a certification with an effective date prior to the date of submission? A147: During the first year of the certification process, certifications postmarked or submitted to the Department by July 1, 2016, may specify a begin date as early as March 27, 2016. Certifications submitted to the Department after July 1, 2016, cannot be backdated. Q148: Can a practitioner submit a certification with a future effective date? A148: Yes, up to 3 months in the future. Q149: Does the 25 count script limit include all prescriptions? A149: Prescriptions in both oral and written form for both controlled and non-controlled substances must be included in determining whether the practitioner will reach the limit of twenty-five prescriptions. Q150: What should a practitioner do if he or she exceeds twenty-five prescriptions within the twelve-month certification period? A150: The practitioner is required to issue prescriptions electronically or obtain a waiver from the requirement to electronically prescribe. Please see information related to electronic prescribing waivers at www.health.ny.gov/professionals.narcotic/electronic_prescribing/waiver.htm Q151: Does my certification need to be approved? A151: There is no review and approval process for certifications. Q152: Who can submit the certification for a practitioner? A152: Each individual practitioner must certify independently. A hospital or group practice organization cannot submit a certification on behalf of the practitioner. Q153: How long is the certification valid? A153: A certification is valid for one year from the begin date.

http://www.health.ny.gov/professionals.narcotic/electronic_prescribing/waiver.htm



Q154: Does a practitioner need to submit a certification each year? A154: Yes. A practitioner must recertify each year. Q155: Can a practitioner submit a certification for a period that begins prior to the end date of its current certification period? A155: No. The certification periods can’t overlap. The begin date of a new certification period must be after the end date of the previous certification. Q156: Does a practitioner who already has an approved waiver from the requirement to electronically prescribe also need to submit a certification? A156: No. The practitioner is covered by the waiver until March 26, 2017. Q157: Does a practitioner who issues less than 25 prescriptions per year and already has an approved waiver from the requirement to electronically prescribe also need to submit a certification? A157: No. The practitioner is covered by the waiver until March 26, 2017.

Resource Information and Contacts Q158: Where can I obtain information regarding the DEA’s federal requirements for EPCS?

A158: You may visit the DEA’s web page for additional information regarding federal security requirements: http://www.deadiversion.usdoj.gov/ecomm/e_rx/. Q159: Where can I obtain information regarding New York State’s requirements for EPCS? A159: BNE has a web page with additional information regarding electronic prescribing of controlled substances: http://www.health.ny.gov/professionals/narcotic/electronic_prescribing/

You may also email BNE at [email protected] Q160: Where can I obtain information regarding Electronic Data Transmission requirements for EPCS? A160: BNE has a web page with additional information regarding electronic data transmission which can be accessed through the following link: http://www.health.ny.gov/professionals/narcotic/electronic_data_transmission/


http://www.health.ny.gov/professionals/narcotic/electronic_prescribing/


http://www.health.ny.gov/professionals/narcotic/electronic_data_transmission/

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